A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated With Finacea Foam for Rosacea

NCT03193372 | Completed

• 1 other identifier: 19638
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief Summary

To survey rosacea patients about their concerns, treatment satisfaction, and quality of life associated with their Finacea Foam treatment

Conditions

Rosacea

Outcome Measures

Primary Outcomes (7)

• Demographics and clinical characteristics

  Collected patient demographics and characteristics are : * Year of birth * Gender * Insurance type

  one-time survey in 2 week recruitment window

• Rosacea-relevant comorbidities and complications

  Patient reported history of the following will be collected : * Blepharitis * Conjunctivitis * Corneal neovascularization/keratitis * Depression * Migraine

  one-time survey in 2 week recruitment window

• Rosacea subtype

  Patient reported diagnosis of the following will be collected: * Erythematotelangiectatic (facial redness) * Papulopustular (bumps and pimples) * Phymatous (enlargement of the nose) * Ocular (eye irritation) * Unknown

  one-time survey in 2 week recruitment window

• Past use of topical rosacea treatments

  Patient reported use of the following medications will be collected: * Metronidazole gel * Metronidazole cream * Metronidazole lotion * Metronidazole emulsion * Brimonidine tartrate gel

  one-time survey in 2 week recruitment window

• Patient concerns collected by Rosacea Treatment Preference Questionnaire

  Rosacea Treatment Preference Questionnaire is a survey to assess patient self-reported rosacea subtype and severity, and to evaluate the concerns that contribute to patient satisfaction/dissatisfaction, as well as treatment decisions with rosacea topical treatments

  one-time survey in 2 week recruitment window

• Treatment satisfaction assessed by Satisfaction with Medicines Questionnaire (SATMED-Q)

  SATMED-Q is a 17-question, validated, multidimensional generic questionnaire designed for use in patients with any chronic disease treated with medicines

  one-time survey in 2 week recruitment window

• Quality of life measured by Dermatology Life Quality Index (DLQI)

  DLQI is a widely used dermatology-related quality of life tool

  one-time survey in 2 week recruitment window

Study Arms (1)

Rosacea Concierge Program

Patients diagnosed with rosacea and currently receiving topical monotherapy with Finacea Foam

Drug: Azelaic Acid (Finacea Foam, BAY39-6251)

Interventions

Azelaic Acid (Finacea Foam, BAY39-6251) DRUG

Finacea Foam, Active substance Azelaic acid

Rosacea Concierge Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with rosacea and currently receiving topical monotherapy with Finacea Foam

You may qualify if:

• At least 18 years of age
• Diagnosis of rosacea by a medical professional
• Currently using Finacea Foam as topical monotherapy for rosacea
• Willing and able to provide voluntary, informed consent to participate in this study

You may not qualify if:

• \- Use of any other topical treatment for rosacea at the time of enrollment

Sponsors & Collaborators

• LEO Pharma: lead
• Bayer: collaborator

Study Sites (1)

Xcenda, LLC

Palm Harbor, Florida, 34685, United States

Location

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Conditions

Rosacea

Interventions

azelaic acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 20, 2017
• Study Start: July 20, 2017
• Primary Completion: August 8, 2017
• Study Completion: November 15, 2017
• Last Updated: April 1, 2020

Record last verified: 2018-10

Locations

US (1)